administration of a molecular complex of resins, polysaccharides and polyphenols in irritable bowel syndrome.

Conditions: Irritable Bowel Syndrome

Summary: this study is aimed to investigate the efficacy and safety of colilen ibs, a medical device made of natural substances, even when taken in addition to other therapies, for the treatment of irritable bowel syndrome.

this is a post market, randomized, double blind, cross-over clinical evaluation that will be conducted in 66 patients with diagnosis of irritable bowel syndrome according to rome iv criteria. as this is a cross-over clinical investigation, each eligible patient will take both the products under investigation, colilen ibs and its placebo. after a 2-week run-in period, at baseline visit each patient included in the study will be randomly assigned to one of the two treatment sequences (i.e., sequence ab and sequence ba), for a 16-week total sequential treatment period (8 weeks for each of the 2 treatment periods) first with verum colilen ibs and then with its placebo, or vice versa. a wash out period (3 weeks) is forecast between the two treatment periods.

Eligibility criteria:
inclusion criteria: * 1. male or female patients aged 18 to 75 years (inclusive); * 2. diagnosis of ibs according to rome iv criteria (appendix 3); * 3. abdominal pain score ≥ 4 on a 11-point nrs, on at least 2 days of the 14 days prior to the baseline visit and on at least 2 days of the last 14 days of the washout period, and pain score not \> 8 in more than 7 days of each of the two above-mentioned periods; * 4. signed informed consent; * 5. patients' ability to comply with the study procedures; * 6. stable diet in the two months prior to the screening visit; * 7. \*negative colonoscopy, defined as the absence of clinically relevant changes or of changes nonetheless relevant in relation to study participation risk, performed during the run-in period, unless: * a colonoscopy was performed within the previous 5 years and was negative as intended above, or, if more than one was performed within the previous 5 years, the last being negative as intended above; * the symptoms, if any, for which the last colonoscopy was performed, have remained unchanged; * 8. postmenopausal female patients, i.e., females who have not had a menstrual period for at least 12 months or women who have undergone surgical sterilisation (tubal ligation or ovary removal). if not, women of childbearing potential must follow reliable contraceptive treatment. * inclusion criteria applicable only for patients \> 50 years of age exclusion criteria: * 1. patients taking treatments that may significantly affect the efficacy outcomes measures, such as: probiotics and prebiotics (unless contained in milk-derived foods such as yogurt and cheese); drugs with adsorbent/sequestrant properties such as diosmectite; 5-ht3 receptor antagonist drugs, e.g. ondasetron; drugs that modify gastro-intestinal motility, e.g. "final" anti-cholinergic agents such as loperamide, or cholinergic agents; laxatives and faecal softeners) unless they have been taken at a stable dose for at least four weeks prior to the screening visit. * 2. patients taking tricyclic antidepressants within six months prior to the screening visit; * 3. patients taking opioid-containing analgesics within one month prior to the screening visit; * 4. patients taking antibiotics within one month prior to the screening visit; * 5. patients with relevant organic, systemic or metabolic disease, or laboratory changes, that are deemed significant based on specific ranges of normality; * 6. patients with organic bowel diseases; * 7. patients with unstable psychiatric conditions; * 8. patients who have undergone major abdominal surgery, except appendectomy; * 9. known hypersensitivity to one or more of the components of the products. * 10.women with known or planned pregnancy or breastfeeding; * 11.patients with malignancies of any type, or with a history of prior malignancies, except for patients with a history of extra-intestinal malignancies that have been surgically removed and have not relapsed within the five years prior to participation.

Keywords: irritable bowel syndrome colilen ibs abdominal pain ibs